Kornimate/medical-research-clean huggingface dataset:
a trial of docusate sodium and sorbitol rectal solution for the in patients with constipation

Conditions: Constipation

Summary: this study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol rectal solution produced by ferring pharmaceutical (china) ltd. in treating chinese patients with constipation.


Eligibility criteria:
inclusion criteria: * have signed the informed consent form and have been verbally told of the details of the trial and treatment procedures * is a citizen of the people's republic of china * males and females aged between 18 and 65 years inclusive * a history of constipation symptoms for at least 6 months, with occurrence of two or more of the symptoms during the 3 months before screening: 1. more than 1/4 of stool classifiable as type i or type ii on the bristol stool scale; 2. sensation of incomplete evacuation at least 1/4 of the time; 3. straining during defecation at least 1/4 of the time; 4. sensation of ano-rectal blockage or obstruction during defecation at least 1/4 of the time; 5. manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation) at least 1/4 of the time; 6. fewer than 3 bowel movements per week * no bowel movement within two days prior to randomisation exclusion criteria: * patients who are suspected to have colorectal cancer; * patients showing signs of bleeding in the digestive tract or inflammatory bowel disease; * patients experiencing abdominal discomfort or intestinal blockage for which the cause has yet to be determined; * patients allergic to docusate or sorbitol; * patients allergic to glycerine; * those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control（i.e. an iud (intrauterine device), oral contraceptives or other obstructive measures; * severe liver damage (alt (alanine aminotransferase), ast (aspartate transaminase), tbil (serum total bilirubin) more than 2 times the upper limit of normal) * kidney function impairment (cr (creatinine clearance rate), bun (blood urea nitrogen) more than 1.5 times the upper limit of normal) * patients who have participated in any other clinical trial during the last 3 months; * diabetics who are currently undergoing insulin treatment; * patients who are unable to suspend using treatments that affect the kinetics of the digestive system in the 5 days prior randomisation. such treatments include prokinetic drugs, erythromycin analogues, laxatives, etc; * other patient factor(s) (e.g. medical history, concurrent illness(es), laboratory test result(s), etc.) at screening that in the opinion of the investigator(s) would put the trial patient at excessive risk; * patients who are unable to act in a legal capacity, unable to meet or perform study requirements, or are known or suspected as unable to comply with the study protocol.
lvhr multicenter study

Conditions: Ventral and Ventral Insicional Hernia

Summary: the study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.

patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation. primary endpoint is recurrence. secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. patients are followed 3 years after operation with clinical examination. 300 patients are planned included in primary study. a subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.

Eligibility criteria:
inclusion criteria: * secondary or primary ventral hernia exclusion criteria: * loss of domain, giant hernia with need of abdominal plastic operation, asa score above 3

Keywords: laparoscopy, ventral, hernia, repair, surgery
study of association of anti-inflammatory and anti-rheumatic

Conditions: Osteoarthritis

Summary: phase iii study, double-blind, comparing association of anti-inflammatory and anti-rheumatic in 375 subjects with knee osteoarthritis.

evaluation after 12 weeks of treatment, in 3 arms, the efficacy and safety of the association.

Eligibility criteria:
inclusion criteria: * signs the informed consent form * age between 40 and 85 years * osteoarthritis of the knee according to clinical and radiological criteria of the american college of rheumatology exclusion criteria: * cardiovascular disease * serious chronic comorbidity * hypersensitivity to any component of the study drugs * body mass index\> 30 kg / m²

Keywords: pain knee
intestinal ultrasound for the evaluation of pouchitis and other outcomes after ileal pouch-anal anastomosis

Conditions: Ulcerative Colitis; Pouchitis

Summary: intestinal ultrasound (ius) has been studied in the evaluation of inflammatory bowel disease (ibd) and is increasingly used as a non-invasive, easy to use, cost-effective tool for point-of-care to assess disease activity and more recently to predict response to treatment. however, there is a paucity of data on the use of ius specifically for ulcerative colitis (uc) patients with an ileal pouch-anal anastomosis (ipaa).

aims: 1. establish normal sonographic parameters in patients with an ipaa and normal pouch function. 2. evaluate the feasibility of ius for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.

Eligibility criteria:
inclusion criteria: * adults (age ≥ 18 years) * diagnosis of ulcerative colitis (uc) * status post ileal pouch anal anastomosis ipaa (completed all stages) exclusion criteria: * pediatric patients * indeterminate colitis * status post ipaa for familial adenomatous polyposis (fap) * bmi \> 30 kg/m2 * pregnant * decompensated cirrhosis * inability to provide informed consent

Keywords: ileal pouch anal anastomosis
study of multiple doses of saxagliptin (bms-477118)

Conditions: Type 2 Diabetes Mellitus

Summary: to evaluate the positive efficacy trend among doses of saxagliptin (bms-477118) in subjects with type 2 diabetes mellitus by assessing the change from baseline in hba1c following 12 weeks of double-blind treatment.


Eligibility criteria:
inclusion criteria: * type 2 diabetes who are drug-naive * screening hba1c ≥ 6.8% and ≤ 9.7% * screening fasting or random c-peptide \> 0.5 ng/ml * \< 35 years old must be negative for anti-gad antibodies * body mass index \< 35 kg/m2 exclusion criteria: * symptoms of poorly controlled diabetes * history of diabetic ketoacidosis, hyperosmolar nonketotic coma, or insulin therapy within one year of screening * receipt of oral antihyperglycemic medications for more than six months in total since diagnosis * significant cardiovascular history
optimal timing for repair of right-to-left shunt lesions

Conditions: Congenital Disorders

Summary: the primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as tetralogy of fallot defects. the secondary aim being define the criteria for failing medical therapy.

in the past, children with right-to-left shunt lesions such as tetralogy of fallot defects were palliated with a systemic to pulmonary artery shunt. this prevented cyanosis while the child grew to a size where complete repair could be undertaken. with the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. these operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia. study design and methodology: retrospective chart review - approximately 75 patients preoperative data: diagnosis operative data: age and weight at surgery type of surgical procedure whether pulmonary valve is spared postoperative data: length of time on ventilator length of time on inotropes length of icu stay length of hospital stay complications

Eligibility criteria:
inclusion criteria: * patients in the congenital surgery database who have undergone repair of a tetralogy of fallot defect exclusion criteria: * those who do not meet inclusion criteria

Keywords: pediatric cardiac repair of right to left shunt lesions tetralogy of fallot defects
hypertension and sleep disordered breathing in pediatrics

Conditions: Hypertension; Obstructive Sleep Apnea

Summary: the primary objective is to determine the prevalence of sleep disordered breathing in children with primary hypertension or pre hypertension. the secondary objectives are to determine any association factors for children with primary hypertension or prehypertension to have sleep disordered breathing be it gender, age, body mass index (bmi), family history (hx) or ethnic group.

this is an exploratory, cross sectional study involving identification of the children of the age between 10 years and 17 years diagnosed with primary hypertension who have not been previously diagnosed and or treated for sleep disordered breathing with the revised pediatric sleep questionaire (psq) for sleep disordered breathing. the subjects that have shown interest will be mailed the informed consent/assent form to tbe reviewed. the consent/assent form will be handed to the child and all their questions and concerns will be answered in a comprehensible manner.

Eligibility criteria:
inclusion criteria: * aged 10 to 17 years old diagnosed with primary hypertension exclusion criteria: * refused to participate in the study * children to secondary hypertension * previously diagnosed with sleep disordered breathing

Keywords: hypertension obstructive sleep apnea pediatrics
tobacco retraining of automatic approach to treat individuals with tobacco dependence and severe concurrent disorders.

Conditions: Tobacco Retraining of Automatic Approach; Placebo Task

Summary: a randomized control trial evaluating a novel smoking cessation intervention in individuals at a an inpatient clinic for clients with addiction and concurrent disorders. the intervention is based on cognitive bias modification, where participants are explicitly or implicitly trained to make avoidance movements by pushing a joystick in response to pictures of smoking, and as a result altering their cognitive biases towards smoking and tobacco dependence. hypothesis: participation in the experimental (tobacco-avoidance) condition will induce reduction of smoking, assessed as lower levels of carbon monoxide measured at baseline and 12 week follow-up.


Eligibility criteria:
inclusion criteria: * proficiency to read and write english * a minimum score of 5 or higher on the fagerström test for nicotine dependence, indicating a medium dependence * current smoking will be validated by carbon monoxide breath monitor exclusion criteria: * patients not yet stabilized enough to allow for regular participation in the intervention
comparison between positive and negative supp

Conditions: Urodynamic Stress Incontinence

Summary: urodynamic stress incontinence is a prevalent condition among women, characterized by involuntary urine leakage during activities that increase intra-abdominal pressure, such as coughing, sneezing, or physical exertion. stress urethral pressure profile measurement is an important diagnostic tool used during urodynamic studies to assess urethral function. in some women with urodynamic stress incontinence, involuntary urine leakage occurs during this measurement, yet the clinical and urodynamic significance of this leakage remains unclear. this study aims to elucidate the differences in clinical and urodynamic findings between women with urodynamic stress incontinence who experience involuntary urine leakage during stress urethral pressure profile measurement and those who do not. between july 2009 and december 2023, a total of 481 women with urodynamic stress incontinence were included and divided into positive and negative supp groups. the medical records, including urodynamic study, 3-day bladder dairy and questionnaires regarding lower urinary tract symptoms were reviewed.

hypothesis / aims of study involuntary urine leakage has been observed during stress urethral pressure measurement in women with urodynamic stress incontinence (usi). however, to our knowledge, its clinical significance and urodynamic association remained undetermined. therefore, the objective of this study is to elucidate the above differences between those with versus without involuntary urine leakage during the measurement of stress urethral pressure in women with usi. study design, materials and methods between july 2009 and december 2023, medical records, including urodynamic data, bladder dairy data and questionnaires, including patient perception of bladder condition (ppbc), urgency severity scale (uss), overactive bladder symptom score (oabss), urogenital distress inventory (udi-6), incontinence impact questionnaire (iiq-7), and king's health questionnaire (khq), of all women with usi were reviewed to see if there was any involuntary leakage of urine during stress urethral pressure measurement. stata software was used for statistical analysis. the wilcoxon rank sum test or the chi-square test were used for statistical analysis, as appropriate. a p \< 0.05 was considered statistically significant. linear regression analysis was also performed with an adjustment of overactive bladder syndrome (oab) to elucidate the real clinical and urodynamic associations about the leak during stress urethral pressure measurement.

Eligibility criteria:
inclusion criteria: * \>20 y/o * women with lower urinary tract symptoms * received urodynamic stress incontinence and was diagnosed with urodynamic stress incontinence exclusion criteria: * women who are pregnant * with chronic pelvic inflammatory disease

Keywords: urodynamic stress incontinence
safety and efficacy of autologous adipose-derived stem cell transplantation in patients with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to determine whether intravenous administration of autologous adipose stem cells is safe and beneficial in patients with type 1 diabetes.

diabetes mellitus is of large epidemic proportions worldwide. it is proliferating at such a fast rate that new novel drugs and other therapeutic approaches are required. the purpose of this phase i/ii study is to determine whether the intravenous administration of activated adipose-derived stromal vascular fraction as a single procedure is safe and efficacious in patients with type 1 diabetes mellitus. patients will be observed over 12 months following the procedure, with 2 weeks, 1 month and tri-monthly diagnostics and life style questionaires.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of type i diabetes for at least 2 years * insulin-dependent exclusion criteria: * presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cva or acute renal failure.

Keywords: diabetes mellitus adipose-derived stem cells adipose stromal vascular fraction autologous insulin-dependence
a study of mtp-131 topical ophthalmic solution in subjects with diabetic macular edema and non-exudative intermediate age-related macular degeneration

Conditions: Diabetic Macular Edema; Age-related Macular Degeneration

Summary: this is a phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose mtp-131 given twice a day in subjects with diabetic macular edema and age-related macular degeneration.


Eligibility criteria:
inclusion criteria: * general: 1. adults aged ≥18 and ≤ 80 years 2. women of childbearing potential must have a negative urine pregnancy test at baseline and agree to use a highly effective method of contraception throughout the study and 60 days after the last dose of study drug. * dme treatment group: 1. central subfield thickness (cst) ≥325 microns as measured by spectral domain optical coherence tomography (sd-oct) at screening and baseline visits 2. bcva (etdrs) no better than 20/25 in the study eye 3. bcva (etdrs) no worse than 20/640 in either eye * amd treatment group: 1. non-exudative, intermediate age-related macular degeneration defined as an eye(s) having extensive intermediate drusen (10 or more drusen 63μm - 124μm) or large drusen (1 or more ≥125 μm) with no evidence of advanced amd (i.e., no choroidal neovascularization or macular atrophy) 2. bcva (etdrs) no worse than 20/400 in either eye exclusion criteria: * general: 1. inability to self-administer eye drops 2. current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve (for example deferoxamine, chloroquine/hydroxychloroquine \[plaquenil\], tamoxifen, phenothiazines and ethambutol) 3. any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or completion of all study requirements and examinations 4. have a glycosylated hemoglobin (hba1c) ≥ 12% * ocular conditions: 1. any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity or successful completion of any study examination 2. ocular hypertension or glaucoma, dry eye, and any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops * other protocol-defined inclusion/exclusion criteria may apply

Keywords: macular edema macular degeneration mtp-131 ocuvia™
human leukocyte antigen (hla) mismatched related allogeneic hematopoietic stem cell transplantation

Conditions: Hematologic Diseases

Summary: this study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo hsct) but lack suitable donors. this project plans to use human leukocyte antigen (hla) mismatched donors. ultimately, a hla mismatched allo hsct transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".

this study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo hsct) but lack suitable donors. this project plans to use human leukocyte antigen (hla) mismatched donors. ultimately, a hla mismatched allo hsct transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".

Eligibility criteria:
inclusion criteria: * adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation with no available related human leukocyte antigen (hla) identical sibling donors; * no available donor with hla high-resolution typing ≥ 9/10 or those who have difficulty finding donors due to urgent medical conditions; * no suitable hla matching haploidentical donor available; * there is a suitable donor with mismatched hla typing; * the subjects or their legal representatives shall sign an informed consent form before the start of the clinical study. exclusion criteria: * patients with severe liver and kidney function (alanine aminotransferase\>2.5 times the upper limit of normal, blood creatinine\>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (new york heart association (nyha) iii/iv heart function, ejection fraction\<50%, severe obstructive or restrictive ventilation dysfunction); * merge active infections; * eastern cooperative oncology group (ecog) score ≥ 2 points; * secondary tumors with merged activity; * severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials; * combine other allo hsct contraindications.

Keywords: hematopoietic cell transplantation hla mismatch related hematologic diseases
laryngeal mask airway (lma) insertion with sevoflurane and remifentanil

Conditions: Laryngismus

Summary: the purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the lma insertion during inhaled induction with 8% sevoflurane in adults.

for practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the lma during anaesthesia induction. to date, however, there have been no published reports addressing the use of remifentanil to facilitate lma insertion during sevoflurane inhalation induction in adults. therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (tci) for the lma insertion during inhaled induction with 8% sevoflurane in adults.

Eligibility criteria:
inclusion criteria: - adult patients, aged 18-60 with asa physical status i or ii, who were scheduled to minor elective surgery (\< 1 h) were considered for the study exclusion criteria: - exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index \> 30 kg/m2) and suspected difficult airway

Keywords: laryngeal mask airway insertion sevoflurane remifentanil
transcranial direct current stimulation (tdcs) in human subjects with ptsd receiving an exposure-based, behavioral therapy

Conditions: Post Traumatic Stress Disorder

Summary: the primary objective of this study is to evaluate the safety, feasibility, and psychological and physiological treatment benefits of transcranial direct current stimulation (tdcs), a noninvasive brain stimulation technique, when delivered in combination with written exposure therapy (wet), for posttraumatic stress disorder posttraumatic stress disorder (ptsd).

while the potential for non-invasive brain stimulation is exciting, research is needed to determine the safety, feasibility, and benefits of non-invasive brain stimulation in human subjects with ptsd. towards this end, the study team will conduct a single-blind randomized controlled pilot study of transcranial direct current stimulation (tdcs) vs. a sham condition in a sample of 40 adults with ptsd receiving 5 weekly sessions of written exposure therapy (wet), an exposure-based, behavioral psychotherapy for ptsd.

Eligibility criteria:
inclusion criteria: 1. individuals between the ages of 18 and 65 years old at time of screening. 2. ptsd diagnosis as assessed by the clinician-administered posttraumatic stress scale (caps-5) 3. able to write, read, and speak english exclusion criteria: 1. history of epilepsy or seizures. 2. history of significant intracranial pathology (e.g., severe traumatic brain injury) or neurological disorder (e.g., stroke, multiple sclerosis, amyotrophic lateral sclerosis, alzheimer's, dementia, parkinson's, and/or huntington's). 3. history of skin condition (e.g., eczema, psoriasis) where electrodes will be applied. 4. electronic implants in the body that could be susceptible to electrical current (e.g., cardiac pacemaker, cochlear implants, medical pump). 5. metallic objects other than dental appliances/fillings near the site of stimulation 6. current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgement). 7. current moderate or severe substance use disorder. 8. suicidality and/or psychiatric risk requiring immediate intervention or a higher level of care than can be provided by the study treatment. 9. change in anticonvulsive or benzodiazepine medication regimen in the past month. 10. history of adverse effects to previous tdcs or other brain stimulation technique. 11. concurrent engagement in another brain simulation technique or trauma-related psychotherapy for ptsd. 12. currently pregnant or breastfeeding.

Keywords: brain stimulation